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  • Regulatory NewsRegulatory News

    EC details device assessment capacity amid COVID-19

    European notified bodies reported on their ability to conduct conformity assessment quickly for COVID-19-related medical devices and in vitro diagnostic medical devices, in response to a survey conducted by the European Commission (EC).   The survey sought to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the European Union (EU) and for which notified bodies need to be involv...
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    EMA, HMA consult on next 5-year network strategy

    The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) on Monday released their next five-year network strategy aimed at steering the regulators through a “time of rapid charge” for a two-month public consultation .   The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies’ previous network strategy to 2020. (RELATED: EU regulators ...
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    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
  • ReconRecon

    Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House teases executive orders on China, immigration and prescription drugs ( Politico ) Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise ( Reuters ) ( Press ) 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons ( KHN ) FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing ( ABC...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan .   Potential therapies are being...
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    Radiologists to FDA: Autonomous AI not ready for prime time

    Artificial intelligence is not ready for autonomy in radiology, according to two radiological professional associations who asked the US Food and Drug Administration (FDA) to wait for more rigorous testing and surveillance of the modality before authorizing its autonomous implementation in medical imaging.   In follow-up to a February 2020 workshop focused on artificial intelligence (AI) in medical imaging, the chairs of the American College of Radiology (ACR) and th...
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    Update: RAPS Convergence 2020 goes live online this September

    The RAPS Convergence conference will transition to a virtual-only experience for the first time ever in 2020, with two registration options for its upcoming annual event, which was originally planned to convene in San Antonio, TX. In addition, the event dates have been adjusted slightly to accommodate the new format and will take place 13–16 September. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only U.S. event e...
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    RAPS publishes updated, ninth edition of essential European regulatory affairs reference

    RAPS has just published the updated, ninth edition of Fundamentals of EU Regulatory Affairs . The book remains the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices and biologics for the European market. As the regulation of healthcare products in the EU continues to undergo significant transformation, RAPS’ Fundamentals of EU Regulatory Affairs, Ninth Edition , has been updated to cover topics including the latest informa...
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    Report calls for limits on compounded bioidentical hormone therapy

    Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA), according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   FDA requested the NASEM review due to increasing popularity of compounded bioidentical hormone therapies (cBHT) combined with concerns over he...
  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • RoundupsRoundups

    EU Regulatory Roundup: EMA seeks feedback on veterinary antimicrobial plan

    A proposed strategy document from the European Medicines Agency (EMA) would require post-authorization trials of veterinary antimicrobials to ensure the benefit-risk balance of a product remains positive, among other requirements. Such studies could cut the risk of the continued use of products that are driving the evolution of antibiotic-resistant bacteria.   The proposal reflects EMA’s decision to make mitigating the threat posed by antimicrobial resistance a key str...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...